# US 12,599,361 B2 · Ultrasonic imaging system and method > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,599,361 B2 - Document ID: US12599361B2 - Status: Granted - Kind: B2 - Application number: 18/168,786 - Filed: 2023-02-14 - Published: 2024-08-15 - Granted: 2026-04-14 - Earliest claimed: 2023-02-14 - Assignees: Boston Scientific Scimed, Inc. - Applicants: Boston Scientific Scimed, Inc. - Inventors: Donald Masters; Jesus Andres Lopez; Shephal Kirit Doshi; Eric Stoppenhagen - Web page: https://patentgrep.com/patent/US12599361B2 ## CPC - A61B 8/12: in body cavities or body tracts, e.g. by using catheters - A61B 8/0883: {for diagnosis of the heart} - A61B 8/445: {Details of catheter construction} - A61B 8/4483: {characterised by features of the ultrasound transducer} - A61B 8/4488: {the transducer being a phased array} - B06B 1/0622: {on one surface} - B81B 7/02: containing distinct electrical or optical devices of particular relevance for their function, e.g. microelectro-mechanical systems [MEMS] (B81B7/04 takes precedence) - B81B 2207/053: of movable structures - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - B06B: METHODS OR APPARATUS FOR GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS OF INFRASONIC, SONIC, OR ULTRASONIC FREQUENCY, {e.g.} FOR PERFORMING MECHANICAL WORK IN GENERAL (for particular applications, see the relevant subclasses, e.g. B07B1/40, B23Q17/12, B24B31/06; measurement of mechanical vibrations G01H; in direction finding, locating, distance or velocity measuring G01S; {generating seismic energy G01V1/02}; control of mechanical vibrations in general G05D; sound-producing devices, e.g. bells, sirens, whistles G10K, {e.g. methods or devices for transmitting, conducting, or directing sound in general G10K11/00}; generation of electrical oscillations H03B; electromechanical resonators in general H03H; electromechanical transducers {for communication techniques, e.g. microphones, speakers} H04R) - B81B: MICROSTRUCTURAL DEVICES OR SYSTEMS, e.g. MICROMECHANICAL DEVICES (piezoelectric, electrostrictive or magnetostrictive elements per se H10N30/00, H10N35/00) ## Abstract An ICE imaging system is disclosed, which comprises an Intracardiac echocardiography (ICE) catheter having a longitudinal axis, a proximal end, and a distal end. The ICE catheter corresponds to a micro-electromechanical (MEMS) or other transducer based phased array ultrasound catheter with an out diameter of 6 French or smaller for delivery through an internal jugular, subclavian, axillary, innominate venous system into heart chambers for the purpose of lead placement for a pacemaker or other implantable cardioverter defibrillator (ICD) device. Further, a catheter shaft houses an electronic flex cable which is in communication with at least one signal trace, and is configured to direct a plurality of transducer array elements to transmit and receive ultrasound beams, receive at least one signal from the plurality of transducer array elements, and construct at least one image of at least a portion of the heart based on the at least one signal. ## Claims ### Claim 1 An Intracardiac echocardiography (ICE) imaging system comprising: an ICE catheter having a longitudinal axis, a proximal end, and a distal end, wherein the ICE catheter is 6.0 French or smaller allowing access to heart and vascular structures; an ultrasonic transducer array disposed within the distal end of the ICE catheter, wherein the ultrasonic transducer array comprises a substrate and a plurality of transducer array elements arranged on the substrate, wherein each of the plurality of transducer array elements has transducer cells of multiple diameters; and a catheter shaft connected at one end to a handle assembly and at other end to the ultrasonic transducer array, wherein the catheter shaft houses an electronic flex cable which is in communication with at least one signal trace, and is configured to: direct each of the plurality of transducer array elements, via the at least one signal trace, to transmit and receive, with respect to the heart, ultrasound beams; receive at least one signal from the plurality of transducer array elements based on transmitting and receiving at least one ultrasound beam of the ultrasound beams; and construct at least one image of at least a portion of the heart based on the at least one signal. ### Claim 2 (depends on 1) The ICE imaging system of claim 1, wherein the ICE catheter is 6.0 French or smaller allowing joint deployment of the 6.0 French or smaller catheter and the pacemaker defibrillator or implantable cardioverter defibrillator (ICD) leads. ### Claim 3 (depends on 2) The ICE imaging system of claim 2, wherein the ICE catheter is 6.0 French or smaller allowing confirmation of pacemaker defibrillator or other ICD lead placement. ### Claim 4 (depends on 1) The ICE imaging system of claim 1, wherein the ultrasonic transducer array corresponds to a micro-electromechanical (MEMS) based Piezoelectric Micromachined Ultrasonic Transducer (pMUT). ### Claim 5 (depends on 1) The ICE imaging system of claim 1, wherein the ICE catheter comprises a steering control unit positioned within the handle assembly, for articulating a distal tip of the ICE catheter and aligning face of the ultrasonic transducer array towards internal views including an anterior position or a posterior position of the heart. ### Claim 6 (depends on 5) The ICE imaging system of claim 5, wherein the distal tip of the ICE catheter is coated with a material to provide electrical isolation and transmission of ultrasound signals. ### Claim 7 (depends on 5) The ICE imaging system of claim 5, wherein the steering control unit comprises a steering handle and a housing enclosing an actuator and a steering hub, and an internal friction occurs between the actuator and the steering hub, and between the actuator and the housing, which causes the ICE catheter to retain its adjusted configuration without operator attention. ### Claim 8 (depends on 1) The ICE imaging system of claim 1, wherein the ICE catheter corresponds to a mechanical flexible sheath with a marker band, to allow passage into the heart, and form a location on an X-ray image. ### Claim 9 (depends on 1) The ICE imaging system of claim 1, wherein the ICE catheter is coupled to an imaging device using a custom dongle, and the custom dongle is configured to communicate ultrasound transmit pulses and ultrasound receive waveforms between the imaging device and the ICE catheter. ### Claim 10 (depends on 9) The ICE imaging system of claim 9, wherein the custom dongle comprises an interposer having a plurality of pogo pins, board edge connectors or other connection means, attached to a flat circuit board of the handle assembly. ### Claim 11 (depends on 1) The ICE imaging system of claim 1, wherein the catheter shaft encloses a plurality of individual electronic flex cables connected between the handle assembly and the ultrasonic transducer array. ### Claim 12 (depends on 1) The ICE imaging system of claim 1, wherein the ultrasound beams having a bandwidth including a predetermined fundamental mode vibration of each of the plurality of transducer array elements, such that a single array element transmits and receives multiple fundamental mode vibrations simultaneously. ### Claim 13 (depends on 1) The ICE imaging system of claim 1, wherein each of the plurality of transducer array elements achieves a bandwidth of greater than 55%. ### Claim 14 An Intracardiac echocardiography (ICE) catheter comprising: a body having a longitudinal axis and a distal end; an ultrasonic transducer array disposed within the distal end of the body, wherein the ICE catheter is 6.0 French or smaller allowing access to heart and vascular structures; wherein the ultrasonic transducer array comprises a plurality of transducer array elements arranged on a substrate, wherein each transducer array element comprises a plurality of transducers of multiple diameters, with a first group of two or more transducers in a first transducer array element and a second group of two or more transducers in the first transducer array element, and each transducer array element is connected in parallel, and comprising: at least one piezoelectric layer disposed on the substrate; at least one first electrode connected between the at least one piezoelectric layer and a signal conductor; and at least one second electrode connected between the at least one piezoelectric layer and a ground conductor. ### Claim 15 (depends on 14) The ICE catheter of claim 14, wherein the ultrasonic transducer array corresponds to a micro-electromechanical (MEMS) based Piezoelectric Micromachined Ultrasonic Transducer (pMUT). ### Claim 16 (depends on 14) The ICE catheter of claim 14, wherein each of the plurality of transducer array elements is a linear phased array. ### Claim 17 (depends on 14) The ICE catheter of claim 14, wherein the plurality of transducer array elements creates an individual focused beam. ### Claim 18 (depends on 14) The ICE catheter of claim 14, further comprising an electrically isolated shaft to cover a shaft up to an imaging window at the distal end of the body. ### Claim 19 (depends on 18) The ICE catheter of claim 18, wherein the electrically isolated shaft uses Pebax material to cover the shaft up to the imaging window at the distal end of the body. ### Claim 20 (depends on 14) The ICE catheter of claim 14, wherein the ICE catheter comprises a steering handle for articulating a distal tip of the ICE catheter and aligning face of the ultrasonic transducer array towards internal views including an anterior position or a posterior position of the heart. ### Claim 21 (depends on 20) The ICE catheter of claim 20, wherein the distal tip of the ICE catheter is coated with a material to provide electrical isolation and transmission of ultrasound signals. ### Claim 22 (depends on 20) The ICE catheter of claim 20, wherein the steering control unit comprises a housing enclosing an actuator and a steering hub, and an internal friction occurs between the actuator and the steering hub, and between the actuator and the housing, which causes the ICE catheter to retain its adjusted configuration without operator attention. ### Claim 23 An Intracardiac echocardiographic (ICE) imaging system comprising: an ICE catheter having a longitudinal axis, a proximal end, and a distal end; a micro-electromechanical (MEMS) based Piezoelectric Micromachined Ultrasonic Transducer (pMUT) array disposed within the distal end of the ICE catheter, wherein the MEMS based pMUT array comprises a substrate and a plurality of MEMS based pMUT array elements arranged on the substrate, and wherein the MEMS based pMUT array comprises pMUT cells of multiple diameters; and an electronic flex cable connected at one end to a handle assembly and at other end to the MEMS based pMUT array, wherein the electronic flex cable is in communication with at least one signal trace, and is configured to: direct each of the plurality of MEMS based pMUT array elements, via the at least one signal trace, to transmit and receive, with respect to heart, ultrasound beams; receive at least one signal from the plurality of MEMS based pMUT array elements based on transmitting and receiving at least one ultrasound beam of the ultrasound beams; and construct at least one image of at least a portion of the heart based on the at least one signal. ### Claim 24 (depends on 23) The ICE imaging system of claim 23, wherein the MEMS based pMUT array achieves a bandwidth of greater than 55%.